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Upcoming Meetings

On March 4, 2015, from 8:30 a.m. to 3 p.m., the committee will meet in open
session to discuss and make recommendations on the selection of strains to be included in the
influenza virus vaccines for the 2015-2016 influenza season.

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

The committee will discuss biologics license application (BLA) 125544 for CTP13,
a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by
Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and
symptoms and inducing and maintaining clinical remission in adult patients with moderately to
severely active Crohn's disease who have had an inadequate response to conventional therapy;(2)
reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining
fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms
and inducing and maintaining clinical remission in pediatric patients 6 years of age and older
with moderately to severely active Crohn's disease who have had an inadequate response to
conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical
remission and mucosal healing, and eliminating corticosteroid use in adult patients with
moderately to severely active ulcerative colitis who have had an inadequate response to
conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients 6 years of age and older with moderately to severely active
ulcerative colitis who have had an inadequate response to conventional therapy;1
(6) in
combination with methotrexate, reducing signs and symptoms, inhibiting the progression of
structural damage, and improving physical function in patients with moderately to severely
active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing
spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of
structural damage, and improving physical function in patients with psoriatic arthritis; and (9)
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis
who are candidates for systemic therapy and when other systemic therapies are medically less
appropriate.

The committee will discuss new drug application (NDA) 022225, sugammadex
sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of
moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.

The committees will discuss supplemental new drug application 204275-S001,
for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by
GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age
and older. The discussion will include efficacy data, but the focus of the meeting will be safety,
including the adequacy of the safety database to support approval, and whether a large safety
trial to evaluate serious asthma outcomes is recommended.

The Pediatric Ethics Subcommittee of the Pediatric Advisory
Committee will meet to discuss the general topic of how procedural
sedation for nontherapeutic (research) interventions or procedures in
the pediatric population should be considered under the Additional
Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart
D. A brief summary of the subcommittee's discussion will then be
presented to the FDA Pediatric Advisory Committee on Tuesday, March 24,
2015.

The committee will discuss new drug application New Drug Application
204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication
of reduction of thrombotic cardiovascular events including stent thrombosis (events related to
blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery
disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of
narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery
puncture with or without a stent.

On April 17, 2015, the committee will discuss the current knowledge regarding
the conduct of clinical studies and evaluation of clinical study data for flow diverter technology.
FDA is convening this committee to seek expert opinion on scientific and clinical considerations
relating to the study design and existing clinical studies, for flow diverter technology indicated
for the neurovasculature.

Recent Meetings

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows:
The Radiesse device is for hand augmentation to correct volume deficit in the hands.
FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

On February 20, 2015, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.